Clinical Trials Start-Up Specialist

Job description

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, The Cancer Center

Clinical Trials Start-Up Specialist

Research Services Sr. Professional

Position #782529 – Requisition #20743

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The Cancer Center has an opening for a [full-time/part-time] University Staff (unclassified) Clinical Trials Start-Up Specialist position.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.

The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.

The CU Cancer Center’s vision is to “prevent and conquer cancer. Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”

Nature of Work

The CU Cancer Center is looking to hire a full time Start-up Specialist to participate in the implementation and conduct of clinical research trials within the Cancer Center Clinical Trials Office (CCTO) by developing relationships with sponsors and customers.

Professional Field: Clinical Research/Clinical Trials Administration

Supervision Received:   CCTO Senior Project Manager

Supervision Exercised:  N/A

Examples of Work Performed 

  • Serves as main study contact person for the entire CCTO department for new/ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
  • Collaborate with sponsor at a high level to cultivate and expand upon existing relationships.
  • Coordinate and attends site qualification visits for multiple disease sites.
  • Completes feasibility questionnaires for multiple disease sites.
  • Tracks new and declined studies across 10+ disease sites.
  • Completes prioritization documents for PRMC across 10+ disease sites.
  • Submits CDAs for review/negotiation across 10+ disease sites.
  • Participates in Data Safety Monitoring Committee (DSMC) activities.
  • Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents through ongoing training.
  • Negotiates for increasing use of internal resources in order to utilize institutional assets that could result in higher efficiency and quality.
  • Serves as direct liaison with budget and finance, assisting in escalations of contract and budget negotiation with sponsors and CROs.
  • Serves as a direct liaison with sponsor/CRO medical monitors.
  • Facilitates Pipeline Discussions with sponsor/CRO’s across 10+ disease sites.
  • Takes responsibility for meeting internal and external timelines.
  • Attends clinical team meetings and SIV visits as necessary.
  • Assists in escalation of sponsor and CRO related concerns and communication issues.
  • Manages Sponsor Information Portals
  • Serves as back-up to budget assistants for CDA routing across 10+ disease sites.
Salary and Benefits:

The starting salary range (or hiring range) for this position begins at $50,338

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected].

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.



Qualifications
Minimum Requirements

  • BS or BA in Biology, Chemistry,  Physiology, Behavioral Sciences, Nursing , Business Administration, Accounting, Human Biology, Public Policy, Communications, Psychology, or Public Health or related field
  • A minimum of 2 years clinical research experience
Substitution: A combination of education and experience can substitute for the degree on a year-for-year basis.

Required: Applicants must meet minimum qualifications at the time of hire.

Condition of Employment:

Certification & Licensure Required:  Current HIPPA and GCP training; Current Clinical Research Certification (CCRC, CCRA, CCRP) – and/or eligible and willing to sit for next available exam. Must have certification within one year of employment. Failure to complete the certification requirement within one year may be cause for termination.

 Preferred Qualifications:

  • Two (2) years’ oncology experience (clinical or research)
  • Four (4) years’ clinical, research or clinical research experience
  • Experience working with Cancer Therapy Evaluation Program and PI initiated studies
  • Experience working in an academic medical setting
  • Experience in teaching, precepting and mentoring employees to clinical research.
  • Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable

Knowledge, Skills, and Abilities

  • Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task. 
  • Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
  • Demonstrates the quick ability to learn, interpret and master complex protocol information.
  • Knowledge of study budgets and contracts.
  • Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications.
  • Possesses advanced knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
  • Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology


Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Mar 31, 2021
Unposting Date: Ongoing

 

 

 

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Job No:
Posted: 4/1/2021
Application Due: 6/30/2021
Work Type: Full Time
Salary: